In this episode, Mark Domayhn, Partner at JD Lymon Group, joins Duane Mancini to unpack what medtech innovators often miss most: reimbursement isn’t a box to check after FDA—it’s the commercial foundation that determines whether hospitals and physicians can adopt your technology. Drawing on experience across Medtronic, Zimmer, and St. Jude/Abbott, Mark breaks down the “three-legged stool” of coverage, coding, and payment, why clinical evidence must satisfy payer standards (not just FDA), and how to “follow the money” across fragmented U.S. systems. The conversation then dives into the New Technology Add-On Payment (NTAP) program, why it matters for inpatient launches, how breakthrough designation has increased NTAP success, and the major implications of CMS proposing to repeal the alternative pathway—plus what companies can do before the June 9 comment deadline.

Mark Domyahn LinkedIn
JD Lymon Group Website
RAPID Coverage Pathway Information
Duane Mancini LinkedIn
Project Medtech Website
Project Medtech LinkedIn

Thank you to our sponsors: Ward Law and JumpStart Inc.